NMPA Notice On The On-Site Inspection Guidelines Of Enterprise Quality Management Specialized In Medical Device Transportation And Storage Services As Appendix For Medical Device Good Supply Practice
2023-06-06
On May 24, 2023, NMPA releases new guidelines aimed at enhancing the supervision and management of medical device quality. These guidelines will standardize and provide guidelines for on-site inspections of enterprises specializing in medical device transportation and storage services.
The guidelines will be applicable to drug supervision and management departments when conducting on-site inspections for businesses holding a license for medical device transportation and storage services, as well as for daily supervision and inspections of such enterprises. During inspections, NMPA related departments should adhere to the inspection items and corresponding key inspection content outlined in the guidelines and implement the inspection requirements outlined in the enterprise’s “GSP Appendix.” The inspection team will determine the relevant items for inspection and provide written justifications for their selection.
During on-site inspection for medical device transportation and storage services, if all applicable items meet the requirements or can be immediately rectified on-site, the inspection results are considered “passing inspection.” If key items meet the requirements but a certain percentage of general items do not, it is considered a “deadline for rectification,” requiring the enterprise to complete necessary rectification within 30 days. A rectification report must be submitted, and all projects must meet the requirements for permission to be granted. However, if the enterprise fails to meet requirements for key items or if the number of general items not meeting requirements exceeds 10% of the total, the inspection results are classified as “failed inspection.” In such cases, failure to submit a rectification report within 30 days or continued non-compliance during re-examination will result in a written decision denying permission from the drug supervision and management department.
The guidelines define the proportion of general items not meeting requirements as the total number of general items divided by the number of general items minus the number of confirmed reasonable missing items in the general items, multiplied by 100%. Daily supervision and on-site inspections of enterprises specializing in medical device transportation and storage services result in “passing inspection” if all applicable items meet the requirements or can be rectified immediately. The items not meeting the requirements are given a “deadline for rectification.” Violations of regulations will be dealt with according to the law. These guidelines aim to ensure high-quality services and promote the safety and efficacy of medical devices. Enterprises are encouraged to comply with the guidelines to maintain quality and safety standards.
